MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIGRIP FLAVOUR FREE; DENTURE ADHESIVE

Lot Number HX3P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Choking (2464)

Event Date 05/10/2023

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Came in my throat i was choking for 2 hours [choke on medication].Some of it i guess was residue after i took my dentures in my mouth[product residue present].Vomiting [vomiting].Case description: this case was reported by a consumer via call center representative and described the occurrence of choke on medication in a 73-year-old male patient who received double salt dental adhesive cream (poligrip flavour free) cream (batch number hx3p, expiry date 3rd september 2025) for product used for unknown indication.On an unknown date, the patient started poligrip flavour free.On (b)(6) 2023, an unknown time after starting poligrip flavour free, the patient experienced choke on medication (serious criteria haleon medically significant and other: haleon medically significant), product residue present and vomiting.The action taken with poligrip flavour free was unknown.On an unknown date, the outcome of the choke on medication, product residue present and vomiting were unknown.It was unknown if the reporter considered the choke on medication and vomiting to be related to poligrip flavour free.The reporter considered the product residue present to be related to poligrip flavour free.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received from a consumer via call center representative (phone) on 11may2023.The consumer reported that, "i have been using poligrip flavor free 2.4 ounce, last night some of it i guess was residue after i took my dentures in my mouth and came in my throat i was choking for 2 hours, vomiting.How to make that would not happen in future? if i was choke to death, my family would've be calling you, instead of me.Lot: hx3p expiry: 03sep2025.".

• Brand Name: POLIGRIP FLAVOUR FREE
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 17049544
• MDR Text Key: 316395521
• Report Number: 3003721894-2023-00089
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: HX3P
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1) NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male